The prescription device uses a pneumatic sensor to measure respiratory rate, body movement, and continuous heart rate, along with tracking sleep cycles, duration, and interruptions.
Summary: The US FDA has granted 510(k) clearance to a contactless, under-the-mattress device designed to aid in the diagnosis of obstructive sleep apnea (OSA). The device is clinically validated for home screening, using sensors to monitor sleep, breathing, and cardiovascular activity. The device aims to improve early diagnosis and management of OSA while reducing healthcare costs.
Key Takeaways:
- FDA clears device for home-based sleep apnea screening: The newly approved under-the-mattress device offers a contactless method for aiding in the diagnosis of obstructive sleep apnea in adults at home.
- Sensors monitor key health metrics: The device uses sensors to track respiratory rate, body movements, and cardiovascular activity, providing an analysis of sleep quality and breathing disturbances linked to sleep apnea.
- Supports early diagnosis and cost-effective care: The device aims to facilitate earlier diagnosis of sleep apnea and reduce healthcare costs by allowing for home-based monitoring as part of clinical sleep management programs.
The US Food and Drug Administration has granted 510(k) clearance to Withings’ Sleep Rx mat, a contactless, under-the-mattress device to aid in the diagnosis of obstructive sleep apnea (OSA).
Sleep Rx is clinically validated for use in home screening of adults with suspected sleep breathing disorders as an aid for diagnosis of OSA, sleep analysis, and heart rate estimation. The unobtrusive mat requires a one-time setup and fits under any mattress. Once set up, it provides an analysis of sleep, breathing, and cardiovascular activity throughout the night.
It uses a pneumatic sensor to measure respiratory rate, body movement, and continuous heart rate, along with tracking sleep cycles, duration, and interruptions. Sound and motion sensors detect snoring and breathing disturbances, key indicators of sleep apnea. Each morning, Sleep Rx provides a sleep quality score, giving patients an easy-to-understand assessment of their rest.
“We’re thrilled to bring Sleep Rx to the US market,” says Antoine Robiliard, vice president of Withings Health Solutions, in a release. “Enabling earlier and more precise diagnosis, Sleep Rx creates a new sleep apnea diagnosis and management paradigm. We know that a one-night assessment is not sufficient. By enabling more efficient and lower-cost home-based OSA diagnosis, Sleep Rx could not only reduce the staggering $150 billion annual economic burden of undiagnosed sleep apnea but also significantly improve long-term health outcomes.”
Available in the US by prescription as part of clinical sleep management or remote patient monitoring programs, Sleep Rx can be acquired by healthcare professionals through Withings Health Solutions.
Photo caption: Sleep Rx
Photo credit: Withings Health Solutions
